BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 11825624 · Received May 14, 2021

    Report

    Report Number
    3011299751-2021-00165
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    February 28, 2021
    Report Date
    May 14, 2021
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: ASANAD S., KALARN S., KALEEM, M. "POSTOPERATIVE COMPLICATIONS OF AB-INTERNO XEN IMPLANTATION IN PRIMARY ANGLE CLOSURE GLAUCOMA." AM J CLIN EXP IMMUNOL, VOL. 10, NO. 1, 2021, 44-47. WWW.AJCEI.US. ISSN: 2164-7712. FACILITY NAME: MEDICINE. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF GEL STENT BLOCKAGE AND DEVICE MIGRATION ARE ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REPORTED EVENTS OF "BY SIX WEEKS POST-IMPLANT, SLIT LAMP BIOMICROSCOPY REVEALED OBSTRUCTION OF THE STENT LUMEN BY THE IRIS ALONG WITH IRIS PIGMENT DEPOSITS TRAVERSING TO THE DISTAL CONJUNCTIVAL END OF THE STENT WITHIN THE BLEB. THE INTRAOCULAR PRESSURE (IOP) HAD INCREASED TO 24 MMHG. STENT WAS NOTED TO BE DISLOCATED AND CURLED AGAINST THE IRIS WITHOUT CORNEAL TOUCH. RESTARTED ON GLAUCOMA MEDICATIONS AND SCHEDULED FOR REVISION SURGERY. DURING REPOSITIONING VIA AB-EXTERNO APPROACH, STENT WAS DECAPITATED. STENT THEN REMOVED AND IOP LOWERED TO 10 MMHG. IOP REMAINS STABLE WITHOUT GLAUCOMA MEDICATIONS AND RESIDUAL IRIS ATROPHY" WERE NOTED IN THE ARTICLE: "POSTOPERATIVE COMPLICATIONS OF AB-INTERNO XEN IMPLANTATION IN PRIMARY ANGLE CLOSURE GLAUCOMA." AM J CLIN EXP IMMUNOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720887 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention